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FDA clears at-home Skyrizi induction for Crohn’s disease

AbbVie ($ABBV) received FDA approval for subcutaneous induction dosing of Skyrizi in adults with moderately to severely active Crohn’s disease. Patients can now begin treatment at home using an on-body injector, extending that delivery option beyond maintenance therapy. The approved induction schedule is 720 milligrams at weeks zero, two, four and eight; maintenance begins at week 12 and continues every eight weeks. The expanded administration option could make treatment initiation more convenie

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AbbVie meets pivotal hidradenitis endpoint with lutikizumab

AbbVie ($ABBV) reported that lutikizumab met the main endpoint and all eight ranked secondary endpoints in the Phase 3 INTREPID trial for moderate to severe hidradenitis suppurativa. At week 16, 31.4% of treated patients achieved HiSCR75, compared with 23.4% on placebo. That measure requires at least a 75% reduction in abscesses and inflammatory nodules without an increase in abscesses or draining fistulas. The study enrolled approximately 1,400 adults and adolescents and also assessed pain and

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AbbVie’s menstrual-migraine study meets its primary and all ranked secondary goals

AbbVie ($ABBV) reported positive Phase 3 LUNA results for atogepant in menstrual migraine. The study enrolled 468 women and evaluated treatment across three menstrual cycles. Migraine days during the assessed menstrual period fell by 1.20 days with atogepant versus 0.40 days with placebo, producing a statistically significant 0.80-day difference on the primary measure. The trial also met all eight ranked secondary endpoints, and AbbVie said no new safety signals were identified. The company plan

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